Senior Associate Regulatory Affairs

Career Category

Regulatory

Job Description

HOW MIGHT YOU DEFY IMAGINATION?

THE AMGEN CAPABILITY CENTER IN LISBON, PORTUGAL (ACCP) will be home to over 300 multi-national and multi-cultural employees, representing a broad range of cross-functional capabilities, including Commercial, General and Administrative, Information Systems, Research and Development, and more. The ACCP will offer rich career growth and development opportunities, regional and global exposure, and the opportunity to LIVE, WIN and THRIVE in one of Europe’s most attractive cities.

Our ACCP brand-new offices are located in Sete Rios, in the vibrant city center of Lisbon.

If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that read over 10 million patients worldwide. It’s time for a career you can be proud of. Join us.

Senior Associate Regulatory Affairs

Live

WHAT YOU WILL DO

Regional Regulatory Affairs provides European regional regulatory leadership/expertise and execution for the development, registration, and lifecycle management of all Amgen molecules.

We are a team of regulatory professionals who thrive on the challenge and opportunity that leading innovative regulatory challenges provides. Together, we in the regulatory team collaborate cross-functionally to optimally develop Amgen products, leading the regulatory authority interactions to effectively drive our product strategies.

Let’s do this. Let’s change the world. In this vital role you will be assigned to one or more Amgen products and may support a Regional Regulatory Lead (RRL) or lead a program under the supervision of an experienced regulatory lead.

• Execute the regional regulatory strategy and regional regulatory plans.

• Prepare supportive documentation for regulatory deliverables, including the management of clinical trial applications, marketing authorizations, and lifecycle management activities.

• Use of Amgen systems and document management.

• Ensure and support regulatory product compliance.

• Work with policies and SOPs.

• Build effective relationships and communication paths across local and functional organizations.

• Enable efficiencies and seamless execution across the region countries.

WIN

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The energetic professional we seek is a collaborative and communicative person with these qualifications:

Required education:

• Master’s degree (scientific area) OR Bachelor’s degree (scientific area) and 2 years of directly related experience.

Preferred knowledge:

• Degree and in-depth regulatory experience and/or related to the region.

• Depth knowledge of regional countries legislation and regulations related to medicinal products.

Thrive

WHAT YOU CAN EXPECT OF US

• Vast opportunities to learn, develop, and move up and across our global organization.
• A diverse and inclusive community of belonging, where colleagues are empowered to bring ideas to the table, try new things, and act.
• Generous Amgen Total Rewards Plan comprising healthcare, finance, wealth, and career benefits.
• Flexible work arrangements.

Equal opportunity statement

Amgen is an Equal Opportunity employer and will consider you without regard to your race, colour, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Join Us

If you’re seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you’ll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops, and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney diseases, rheumatoid arthritis, and other serious illnesses.

As an organization dedicated to improving